Senior Microbiologist - Sterilization

Medtronic•Cherry Hill, MA

11d•$119,000 - $145,200•Hybrid

About The Position

Sr. Microbiologist Sterilization for Medtronic, Inc located in Danvers, MA. Responsible for products in the form of finished medical devices within the Interventional Vascular/ Cardiac Rhythm Disease Management Business supporting on-market product sterilization validations to include product sterilization validations Microbial Performance Qualification and Process Performance Qualification (MPQs/PPQs). Responsible for coordinating laboratory and sterilization internal audit processes. Responsible for Industrial Ethylene Oxide (EO) Sterilization for Medical Devices and CAPA (Corrective Action Preventive Action). Navigate the complexities of various government and industry regulations to include FDA 21 CFR 820, ISO 11135, ISO13485, ISO 11137, ISO 11737, ISO 14644, and ISO 10993-7. Coordinate Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Commission/Re-commission EO Sterilization Chambers, Sterilization adoptions, and Radiation Dose Audits (Gamma and Ebeam). Leverage Good Manufacturing Practices (GMP), Aseptic Technique, Laboratory Information Mgmt. System (LIMS), Good Laboratory Practice (GLP), and Environmental Monitoring. Responsible for various product sampling for Bioburden and Bacterial Endotoxin testing. Leverage compendial Association for the Advancement of Medical Instrumentation (AAMI) and United States Pharmacopeia (USP) methodologies and techniques. Leverage knowledge from being a Certified Industrial Sterilization Specialist (CISS). Relocation assistance not available for this position. Position is required to be onsite in Danvers, MA, 4 days per week, and permits remote work 1 day per week. #LI-DNI. NOTICE: Pursuant to 20 C.F.R. § 656.10, you are hereby notified that an Application for Permanent Employment Certification will be filed for the job opportunity below. Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer at the U.S. Department of Labor as follows: Certifying Officer U.S. Department of Labor Employment and Training Administration Office of Foreign Labor Certification 200 Constitution Avenue NW, Room N-5311 Washington, DC 20210

Requirements

Masters’ Degree or foreign equivalent in Microbiology, Biology, Chemistry, Biological Engineering, Chemical Engineering or related engineering or scientific field and two (2) years of experience as a Microbiologist, sterilization engineer or related occupation
at least two (2) years’ experience with each of the following: Laboratory and sterilization internal audit; Industrial EO Sterilization for Medical Devices and CAPA; FDA 21 CFR 820, ISO 11135, ISO 13485, ISO11137, ISO11737, ISO 14644, and ISO 10993-7; IQ/OQ/MPQ/PPQ, Commissioning/Re-commissioning for EO Sterilization Chambers, Sterilization adoptions, and Radiation Dose Audits (Gamma and Ebeam); GMP, Aseptic Technique, LIMS, GLP, and Environmental Monitoring; Product sampling for Bioburden and Bacterial Endotoxin testing; Compendial (AAMI & USP) methodologies and techniques
Certified Industrial Sterilization Specialist (CISS)

Responsibilities

supporting on-market product sterilization validations to include product sterilization validations Microbial Performance Qualification and Process Performance Qualification (MPQs/PPQs)
coordinating laboratory and sterilization internal audit processes
Industrial Ethylene Oxide (EO) Sterilization for Medical Devices and CAPA (Corrective Action Preventive Action)
Navigate the complexities of various government and industry regulations to include FDA 21 CFR 820, ISO 11135, ISO13485, ISO 11137, ISO 11737, ISO 14644, and ISO 10993-7
Coordinate Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
Commission/Re-commission EO Sterilization Chambers, Sterilization adoptions, and Radiation Dose Audits (Gamma and Ebeam)
Leverage Good Manufacturing Practices (GMP), Aseptic Technique, Laboratory Information Mgmt. System (LIMS), Good Laboratory Practice (GLP), and Environmental Monitoring
Responsible for various product sampling for Bioburden and Bacterial Endotoxin testing
Leverage compendial Association for the Advancement of Medical Instrumentation (AAMI) and United States Pharmacopeia (USP) methodologies and techniques
Leverage knowledge from being a Certified Industrial Sterilization Specialist (CISS)

Benefits

Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Employee Referral Bonus Program